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Job Description

About the Role:

As the QC Analyst, you will conduct biological or chemical and physical analyses on raw materials, in-process samples, product samples and other samples collected from manufacturing areas.

This position is on site and you will report to the AQC Manager.

How You Will Contribute:

• Use laboratory instrumentation including analytical equipment, autoclaves, and incubators. Perform test equipment, equipment maintenance and calibrations.

• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

• Conduct biological, chemical, and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.

• Investigate nonconformances and write exception documents.

• Perform review of test data, which includes overall documentation practices (CGDP). Perform release functions in LIMS or other computerized systems.

• Prepare monthly quality trend reports,. perform laboratory audits, and audit and update plant SOPs.

• May perform other duties as assigned.

What you bring to Takeda:

• High School degree or equivalent required; bachelor's degree in Chemistry, Microbiology or Biological Sciences is desirable.

• Minimum 1 year of related experience in cGMP lab testing.

• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is desirable.

• General understanding & knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.

• Experience with laboratory safety including standard precautions and hazardous and biohazardous chemical handling. Wet and instrumental methods of analyses are desirable.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• The overall physical exertion of this position requires light to medium work.

• May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours.

• May be required to bend at the neck/waist, squat, and climb (using step stools and ladders), reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours.

• May be required to lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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